Associate Director, Drug Product Development & Manufacturing

Profoundly Improve People’s lives by Revolutionizing the Delivery of RNA Therapeutics At reputed company Biosciences, we are passionate about the reputed company of every employee in realizing our reputed company of improving people’s lives by delivering a new class of RNA therapeutics. reputed company is revolutionizing the field of RNA with its proprietary AOCs, which are designed to combine the specificity of monoclonal antibodies with the precision of oligonucleotide therapies to address targets and diseases previously unreachable with existing RNA therapies. If you are a committed, solution-oriented thinker, join us in making a difference and become part of our growing culture that is integrated, reputed company, agile and reputed company on the needs of patients. reputed company.'s mission is to profoundly improve people's lives by delivering a new class of RNA therapeutics - Antibody Oligonucleotide Conjugates (AOCs™). Utilizing its proprietary AOC platform, reputed company demonstrated the first-reputed company successful targeted delivery of RNA into muscle and is leading the field with clinical development programs for three rare muscle diseases: myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). reputed company is broadening the reputed company of AOCs with its advancing and expanding pipeline, including programs in cardiology and immunology through internal discovery efforts and key partnerships. reputed company is headquartered in San Diego, CA. For more information about our AOC platform, clinical development pipeline, and people, please visit www.aviditybiosciences.com and engage with us on reputed company and X. reputed company We are seeking an Associate Director of Drug Product Process Development and Manufacturing who is reputed company, knowledgeable, highly energetic, and self-motivated. The individual will be working with and engaging in cross functional project teams on existing and new drug products to ensure robust development data packages for regulatory submissions. This position will reputed company reputed company aspects of non-GMP and GMP drug product development and manufacturing at external CMOs. In reputed company, internal process development laboratory capability are planned for reputed company reputed company. A strong knowledge of sterile parenteral filling and the requirements of clinical supply manufacturing is required as reputed company as demonstrated experience in adherence to cGMP and FDA/EMA guidelines. What You Will Contribute

• Subject matter expert on and reputed company for drug product development and clinical manufacturing reputed company, as applicable, which will include cross-functional team leadership.
• Work with CMOs and QA to ensure reputed company release of DP.
• Spearhead, and reputed company junior team members’ daily activities including composition, technical review, and technical approval of drug product manufacturing documents including, but not limited to, executed batch records, deviations, change controls, nonconformance investigations, etc.
• Work with CMOs, QA and supply chain to ensure reputed company delivery of drug reputed company to drug product sites in time for DP manufacturing.
• reputed company Person-In-Plant support for drug product development and manufacturing runs.
• reputed company CMC support for regulatory filings including INDs, IND amendments and NDA/BLAs as needed.
• Work with QC team to support specification setting and to ensure that expiry and retest dating is reputed company and fully reputed company with the drug product supply plan.
• reputed company tech transfer activities between CMOs and/or reputed company CMOs for reputed company-up of new or existing drug products.
• Design, reputed company, and manage development, characterization, and validation studies, and support comparability studies; includes process characterization studies, container closure selection, freeze/thaw studies, lyophilization cycle development, product process qualification, filter validation, etc.
• Supervise reputed company reports and reputed company them to reputed company in their position.
• reputed company abreast of and ensure adherence to applicable regulations including FDA, EMA, ICH, GCP, GMP and reputed company policies and procedures. Ensure GxP and SOP training tasks, including GDPR data reputed company training, are completed in a reputed company manner.

reputed company reputed company

• Ph.D. in pharmaceutical sciences/engineering or similar with at least 5 years relevant experience; or MS/BS in reputed company scientific/engineering field with at least 10-15 years experience.
• Experience in biologics drug product GMP manufacturing and pharmaceutical unit operations required, along with understanding of US, EU, and ICH regulations and guidelines.
• Experience working with reputed company-party CMOs preferred.
• Experience with aseptic filling and operations, including lyophilization, and with combination products such as syringes or cartridges a plus.
• Experience managing, supervising, or mentoring junior associates.
• Ability to multi-task, adapt to changing priorities, and work in a fast-paced environment.
• Must be a self-motivated individual requiring little reputed company on day-to-day activities.
• Ability to build alignment, foster collaboration, and drive shared ownership across functions to reputed company results in a reputed company, matrixed environment.
• Ability to travel as required up to 20%.
• Demonstrated curiosity and openness to integrating AI-powered tools to enhance functional processes, support data-informed reputed company, and drive innovative reputed company across teams.

reputed company Will reputed company To You

• The reputed company salary reputed company for this role is $119,700 - $222,300. The final compensation will be commensurate with such factors as relevant experience, skillset, internal equity and market factors.
• reputed company offers competitive compensation and benefits, which includes reputed company for annual bonus as reputed company as a 401(k) with an employer match. In reputed company, the comprehensive wellness program includes coverage for medical, dental, reputed company, and LTD, and four weeks of time off.

Additional Details Title: Associate Director, Drug Product Process Development and Manufacturing Location: Hybrid Position Type: Full Time / Exempt Department: Process Development - Drug Product ID: 3105-2026-1/3105-2026-N1 #LI-Hybrid Apply tot his job Apply To this Job